Home NDC 52670-552 Ammonia N 13
Product NDC 52670-552
11-digit product format 526700552
Labeler code 52670
Product ID 52670-552_46dfe34a-40c9-373e-e063-6294a90af7cf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ammonia n-13
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Mayo Clinic
Application ANDA203321
Marketing category ANDA
Marketing start 2013-02-25
Substance AMMONIA N-13
Active strength 37.5 mCi/mL
Pharmacologic classes Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203321-001 AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203321-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203321-001 AMMONIA N 13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE / INTRAVENOUS AP 2013-02-25 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ammonia N 13
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMMONIA N-13 37.5 mCi/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9OQO0E343Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52670-552-30 Ammonia N 13 30 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 30 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52670-552 AMMONIA N 13 (AMMONIA N-13) INJECTION, SOLUTION [MAYO CLINIC] 13 Current NDC, Legacy NDC, 1 package rows 20241219_af70d0da-1c2d-44e4-b4cd-7cce6636c7b9.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52670-552-30 52670055230 30 mL in 1 VIAL, SINGLE-DOSE (52670-552-30) 30 ml 2013-02-25 0000-00-00 No No Current